PRECISE: Pancreatic Cancer and Exercise

• ClinicalTrials.gov Identifier: NCT04305067
• Recruitment Status: Completed
• First Posted: March 12, 2020
• Last Update Posted: February 16, 2024
• Sponsor: Queen's University, Belfast
• Collaborators: Pancreatic Cancer UK; Belfast Health and Social Care Trust
• Information provided by (Responsible Party): Gillian Prue, Queen's University, Belfast

Study Description

Brief Summary:

The purpose of this study is to establish the feasibility of delivering a prescribed, individualised supervised aerobic and resistance exercise programme during adjuvant therapy, to improve survival and reduce symptom burden in pancreatic cancer

Condition or disease	Intervention/treatment	Phase
Pancreas Adenocarcinoma	Other: Exercise	Not Applicable

Detailed Description:

Pancreatic ductal adenocarcinoma (PDAC) is the most common malignancy of the pancreas, representing 90% of all pancreatic neoplasms. The late presentation of symptoms and a lack of effective screening methods, means a large proportion (80-90%) are diagnosed with unresectable advanced disease, contributing to an unfavorable prognosis and dismal 5-year survival rate of ~5%. Intensive cancer treatments (i.e. surgery and chemotherapy) have debilitating complications including fatigue, pain and impaired physical function. Therefore, the maintenance of physical function and quality of life are seen as primary treatment goals for pancreatic patients, particularly during adjuvant therapy. Exercise training is emerging as an accepted component of patient care and evidence suggests regular exercise may induce an array of physiological and psychosocial benefits. However, there is a lack of evidence on the feasibility of delivering supervised exercise interventions to individuals with resectable PDAC undergoing adjuvant therapy. This study aims to explore the initial feasibility of delivering a supervised, individualized, and progressive concurrent exercise intervention to individuals with resectable PDAC who are undergoing adjuvant therapy, and provide data required to design a future randomized controlled trials.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: PRECISE: PancREatic Cancer and Individualised Supervised Exercise: a Feasibility Study
• Actual Study Start Date: August 1, 2020
• Actual Primary Completion Date: July 31, 2022
• Actual Study Completion Date: August 1, 2022

Arms and Interventions

Arm

Intervention/treatment

Experimental: Supervised aerobic and resistance exercise; 16 weeks of supervised, moderate intensity, aerobic and resistance exercise. Aerobic exercise will be completed supervised, 2 days per week, commencing with a single 10 minute bout and progressing to 30 minutes of continuous aerobic exercise. Resistance exercises will involve whole body activities and commence with 1 set of each exercise (6-12 repetitions) and progress to 3 sets. The resistance exercises will gradually progress in difficulty throughout the program and will utilise daily undulating periodisation

Other: Exercise; Exercise programs will be individually tailored to the capabilities of each participant and gradually progressed accordingly. Each patient will be asked to complete one home-based aerobic exercise sessions each week. At baseline, 16 weeks and 3 month followup patients will complete a physical fitness assessment (30 second sit to stand and six minute walking tests) and a range of quality of life questionnaires. Upon completion of the 16 week exercise intervention, patients will be invited to partake in semi-structured interviews to determine the effectiveness of the program and their experience throughout.

Outcome Measures

Primary Outcome Measures :

1. Feasibility - recruitment: number of participants that agree to participate or are excluded [ Time Frame: At baseline ]
   The number of participants that agree to participate or are excluded
2. Feasibility - attrition: number of participants that withdraw from the study [ Time Frame: At conclusion of the 16 week exercise intervention ]
   The number of participants that withdraw from the study
3. Feasibility - adherence to the exercise intervention: percentage of participants adhering to the exercise intervention [ Time Frame: At conclusion of the 16 week exercise intervention ]
   Determine the percentage of participants adhering to the exercise intervention
4. Feasibility - participant experience: semi-structured interviews [ Time Frame: At conclusion of the 16 week exercise intervention ]
   Determined by qualitative evaluation, using semi-structured interviews to assess experiences, accessibility and acceptability of the exercise intervention

Secondary Outcome Measures :

1. Anthropometric assessment [ Time Frame: At baseline, 16 weeks, 3 month follow-up ]
   Height will be measured in cm and body weight in k, which will be combined to report BMI in kg/m (squared).
2. Hip and waist circumference analysis [ Time Frame: At baseline, 16 weeks, 3 month follow-up ]
   Hip and waist circumference will be measured in cm.
3. Functional muscle endurance assessment [ Time Frame: At baseline, 16 weeks, 3 month follow-up ]
   The amount of repetitions achieved during a 30 second sit-to-stand test will be recorded.
4. Physical fitness assessment [ Time Frame: At baseline, 16 weeks, 3 month follow-up ]
   Distance covered in meters during a six minute walk test will be recorded.
5. Perceived physical activity levels [ Time Frame: At baseline, 16 weeks, 3 month follow-up ]
   Patients will complete an International Physical Activity Questionnaire (IPAQ-SF). This questionnaire will comprise 4 generic items to obtain comparable health-related physical activity. Patients will detail the number of days, hours and minutes that they undertake (1) vigorous exercise (2) moderate exercise (3) walking exercise and (4) sitting. Total physical activity will be generated and monitored for improvement or decline. Higher reported scores indicate higher levels of self-reported physical activity.
6. Cancer-related fatigue by questionnaire [ Time Frame: At baseline, 16 weeks, 3 month follow-up ]
   Fatigue will be measured by the Functional Assessment of Cancer Therapy - Fatigue (FACIT-Fatigue) questionnaire. Patients will score several fatigue items over the past 7 days on a scale (0 = not at all; 4 = very much), generating a total (0 - 52) with higher scores linked to greater quality of life.
7. Patient rated pain by questionnaire [ Time Frame: At baseline, 16 weeks, 3 month follow-up ]
   Pain will be measured using the Brief Pain Inventory (BPI). Pain is scored on a scale 0 - 10, with higher scores indicating higher pain levels.
8. Well-being by questionnaire [ Time Frame: At baseline, 16 weeks, 3 month follow-up ]
   Quality of life will be measured by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. This questionnaire is scored on a scale of 0 - 4, with 0 indicating not at all, and 4 indicating very much. Higher scores indicate poorer quality of life.
9. Health related quality of life by questionnaire [ Time Frame: At baseline, 16 weeks, 3 month follow-up ]
   Quality of life will be measured by the EuroQOL Five Dimension Questionnaire (EQ5D). Patients will select a level of difficulty (I have no - I have extreme) on that particular days health for mobility, self-care, usual activities, pain / discomfort and anxiety / depression. Patients will then rate 'how good' or 'how bad' their health is on that day using a 100 point scale (0 = worst health you can imagine; 100 = best health you can imagine).
10. Health economics [ Time Frame: At 16 weeks ]
    Health resource use will be evaluated by a Health Economics Questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• age ≥ 18 years
• histologically proven pancreatic ductal adenocarcinoma
• complete macroscopic resection (R0 or R1 resection)
• patients recovering from surgery in time for chemotherapy to be delivered with adjuvant intent
• prior malignancy active within the previous 3 years other than locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• deemed medically fit by treating team to participate in exercise programme
• able to provide informed consent.

Exclusion Criteria:

• Macroscopically remaining tumour (R2 resection or tumour node metastasis (TNM) stage IV disease)
• Pre-existing cardiac conditions; Congestive heart failure or recent serious cardiovascular event
• Chest pain while undertaking physical activity
• Any related co-morbidities (diabetes; unstable angina; degenerative neuromuscular disease; mental health disorders; substance abuse)

Contacts and Locations

Locations

United Kingdom

Belfast City Hospital

Belfast, United Kingdom, BT5 5JU

Sponsors and Collaborators

Queen's University, Belfast

Pancreatic Cancer UK

Belfast Health and Social Care Trust

Investigators

• Principal Investigator: Richard Turkington, MD; Queens University

More Information

• Responsible Party: Gillian Prue, Senior lecturer in chronic illness, Queen's University, Belfast
• ClinicalTrials.gov Identifier: NCT04305067
• Other Study ID Numbers: B19/35
• First Posted: March 12, 2020
• Last Update Posted: February 16, 2024
• Last Verified: February 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No